Prenatal Exposure to Dolutegravir and Pregnancy and Neonatal Outcomes: Data from Antiretroviral Pregnancy Registry (206242)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Descriptive analysis

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Descriptive analysis

Study drug and medical condition

• Name of medicine:
  TIVICAY

  TRIUMEQ
• Study drug International non-proprietary name (INN) or common name:
  ABACAVIR

  DOLUTEGRAVIR

  LAMIVUDINE
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AR13) lamivudine, abacavir and dolutegravir

  lamivudine, abacavir and dolutegravir

  (J05AX12) dolutegravir

  dolutegravir
• Medical condition to be studied:
  Human immunodeficiency virus transmission

Population studied

• Age groups:
  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1

Study design details

• Main study objective:
  1. To describe the demographic and clinical characteristics of pregnant women exposed to dolutegravir (DTG) (Tivicay & Triumeq) ; 2. To assess the frequency of birth defects among neonates, with prenatal exposure to DTG (Tivicay & Triumeq) ; 3. To describe non-defect pregnancy outcomes among live birth
• Outcomes:
  Outcomes of interest are live births, still births, induced abortion, spontaneous abortion, birth defects, low birth weight (LBW), very low birth weight (VLBW) and preterm births.
• Data analysis plan:
  Demographic and clinical characteristics of the pregnant women will be tabulated. Frequency assessment of birth defects will be done among all live births.